Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), and Usability of Abaloparatide-solid Microstructured Transdermal System (sMTS) in Postmenopausal Women With Low Bone Mineral Density (BMD)

February 9, 2023 updated by: Radius Health, Inc.

A Prospective, Single Arm Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Usability of Abaloparatide-sMTS in Postmenopausal Women With Low Bone Mineral Density

This was an open-label, single-center study to evaluate the usability of abaloparatide-sMTS by participants with low BMD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study aimed to evaluate the ability of participants to self-administer 300 μg abaloparatide-sMTS over a period of 29 days based on PK and PD markers.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • Pharmaceutical Research Associates, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Postmenopausal for at least 2 years
  • BMD T-score based on the female reference range <-1.0 and >-5.0 at the lumbar spine (L1-L4) or hip (femoral neck or total hip) by dual energy X-ray absorptiometry (DXA)
  • Good general health as determined by medical history and physical exam (including vital signs, and has a body mass index up to 33 kilograms/square meter (kg/m^2)
  • Laboratory tests within the normal range including serum calcium (albumin-corrected), intact parathyroid hormone (PTH), serum phosphorus, alkaline phosphatase, and thyroid stimulating hormone
  • Serum 25-hydroxyvitamin D values ≥ 20 nanograms per milliliter (ng/mL)

Exclusion Criteria:

  • History of prior external beam or implant radiation therapy involving the skeleton, other than radioiodine
  • History of bone disorders other than postmenopausal osteoporosis (such as Paget's disease)
  • History of cancer within the last 5 years (with the exception of basal cell or squamous cancer of the skin)
  • History of Cushing's disease, hypo or hyperparathyroidism, or malabsorptive syndromes within the past year
  • Prior treatment with PTH, PTH-related peptide-derived drugs, or bone anabolic steroids, including abaloparatide, teriparatide, or PTH (1-84)
  • Prior treatment with intravenous bisphosphonates at any time or oral bisphosphonates within the past year (12 months). Participants who have received a short course of oral bisphosphonate therapy (3 months or less) may be enrolled as long as the treatment occurred 6 or more months prior to enrollment
  • Prior treatment with an investigational drug or device within the past 3 months or 5 half-lives of the investigational drug, whichever is longer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: abaloparatide-sMTS
Abaloparatide-sMTS 300 micrograms (μg) was applied to the thigh for 5 minutes once daily for 29 days.
Combination product: abaloparatide-sMTS
Abaloparatide-sMTS is a drug-device combination product consisting of the drug abaloparatide coated onto an sMTS array for transdermal administration of abaloparatide.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Abaloparatide Maximum Plasma Concentration (Cmax) on Day 29
Time Frame: 0 (predose), 10 minutes, 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours postdose on Day 29
0 (predose), 10 minutes, 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours postdose on Day 29
Abaloparatide Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t) on Day 29
Time Frame: 0 (predose) and 4 hours postdose on Day 29
0 (predose) and 4 hours postdose on Day 29

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline of Serum Procollagen Type I N-Terminal Propeptides (s-PINP) at Day 29
Time Frame: Baseline, Day 29
Blood samples were taken to measure s-PINP, a bone formation marker. s-PINP concentrations reflect the rate of skeletal new bone formation. Increases in s-PINP indicate anabolic biologic response in the bone.
Baseline, Day 29
Change From Baseline of Serum Calcium (Albumin-Corrected) to Predose and Postdose on Day 29
Time Frame: Baseline, 0 (predose) and 4 hours postdose on Day 29
Baseline, 0 (predose) and 4 hours postdose on Day 29
Change From Baseline of Serum Phosphorus to Predose and Postdose on Day 29
Time Frame: Baseline, 0 (predose) and 4 hours postdose on Day 29
Baseline, 0 (predose) and 4 hours postdose on Day 29
Change From Baseline of Cyclic Adenosine Monophosphate (cAMP) to Day 29
Time Frame: Baseline, 0 (predose) and 30-minutes postdose on Day 29
Baseline, 0 (predose) and 30-minutes postdose on Day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radius Health, Inc.

Investigators

  • Study Director: Medical Director, Radius Health, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2019

Primary Completion (Actual)

May 14, 2019

Study Completion (Actual)

May 14, 2019

Study Registration Dates

First Submitted

April 16, 2020

First Submitted That Met QC Criteria

April 24, 2020

First Posted (Actual)

April 29, 2020

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

February 9, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BA058-05-022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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